| CTRI Number |
CTRI/2022/07/044061 [Registered on: 15/07/2022] Trial Registered Prospectively |
| Last Modified On: |
14/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the bioavailability, safety, and efficacy of Resveratrol and Pterostilbene in NOVAGENERE XAR and NOVAGENERE XAP |
|
Scientific Title of Study
|
Open label, randomised, one period one sequence, single dose, pharmacokinetic study to evaluate the bioavailability of Resveratrol and Pterostilbene after administration of single dose of NOVAGENERE-XAR and NOVAGENERE-XAP capsules in six healthy, adult, male human subjects under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Kulkarni |
| Designation |
M.D. |
| Affiliation |
Institute for Advanced Training and Research in Interdisciplinary Sciences |
| Address |
Institute for Advanced Training and Research in Interdisciplinary Sciences,
194, Scheme No. 6, Road No. 15, Sion Koliwada, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
022-24078300 |
| Fax |
|
| Email |
prashantkulkarni256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasikumar Menon |
| Designation |
Director |
| Affiliation |
Institute for Advanced Training and Research in Interdisciplinary Sciences |
| Address |
Institute for Advanced Training and Research in Interdisciplinary Sciences,
194, Scheme No. 6, Road No. 15, Sion Koliwada, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821541776 |
| Fax |
|
| Email |
spmtdmlab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasikumar Menon |
| Designation |
Director |
| Affiliation |
Institute for Advanced Training and Research in Interdisciplinary Sciences |
| Address |
Institute for Advanced Training and Research in Interdisciplinary Sciences,
194, Scheme No. 6, Road No. 15, Sion Koliwada, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821541776 |
| Fax |
|
| Email |
spmtdmlab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Advanced Training & Research in Interdisciplinary Sciences |
|
|
Primary Sponsor
|
| Name |
Epigeneres Biotech Pvt Ltd |
| Address |
Sun Mill Compound, Ikon House, B-Block, Senapati Bapat Marg, Lower parel, Mumbai- 400013 |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Kulkarni |
Institute for Advanced Training and Research in Interdisciplinary Sciences |
Plot no.194, Scheme no.6, Road no.15, Sion-Koliwada, Sion (E), Mumbai 400 022
Mumbai
MAHARASHTRA |
022-24078300
prashantkulkarni256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee C/o Shikshana Prasaraka Mandalis Institute for Advanced Training & Research in Interdisciplinary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
NOVAGENERE-XAR and NOVAGENERE-XAP |
Single-arm, Single-dose, oral Administration of NOVAGENERE-XAR and NOVAGENERE-XAP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
An age between 18 to 45 years (both inclusive), having body mass index (BMI) between 18.5 and 30 Kg/m2, weighing not less than 45 kg
No symptoms of fever, headache, cold, cough, running nose etc. which would indicate possible COVID infection.
No incidence of COVID amongst family members or neighborhood in preceding two weeks (of screening or site visit).
Not been admitted to hospital for COVID in preceding four weeks before the screening date.
A negative COVID – Antigen Test (horizontal Flow) at each site visit. It may be followed by COVID-19 RT-PCR test (if needed) which also should be negative.
No medical history of significant diseases
A physical examination, laboratory evaluations are clinically insignificant
A negative or non-reactive Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV), antibodies to human immune-deficiency Virus (HIV) I and II.
A negative breath alcohol test
A negative urine test for drugs of abuse
Normal clinical parameters on physical examination.
Vital signs examination that are within clinically acceptable limits
No significant medical complaints
No significant allergies especially for peanuts, grapes. |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to grapes or resveraterol or peanuts or any inactive ingredients or related drugs.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
History or presence of significant alcoholism or drug abuse in the past one year.
History or presence of significant smoking and use of tobacco products.
History or presence of significant asthma, urticaria or other allergic reactions.
History or presence of significant gastric and/or duodenal ulceration.
History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
History or presence of cancer.
History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
Presence of disease markers of HIV1 or 2, Hepatitis A, B viruses and syphilis.
Difficulty with donating blood.
Difficulty in swallowing solids like Lozenges or capsules.
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 60/minute or more than 100/minute.
Oral temperature less than 35oC or more than 37.5oC.
Respiratory rate less than 12/minute or more than 20/minute
Use of any prescribed medication during last two weeks or OTC medicinal products and grapefruit juice and 48hrs prior to initiation of study.
Major illness during 3 months before screening.
Participation in a drug research study within past 3 months.
Donation of blood in the past 3 months before screening. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pharmacokinetics of Resveratrol and Pterostilbene after administration of single dose of Novagenere-XAR and Novagenere-XAP Capsules |
0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety and tolerability of Novagenere-XAR and Novagenere-XAP Capsules |
0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
15/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Resveratrol is a polyphenol that is abundant in grape skin and
seeds. Food sources of resveratrol include wine,
berries, and peanuts. This compound has many properties, including activity
against glycation, oxidative stress,
inflammation, neurodegeneration, several types of cancer, and aging. Because
resveratrol is generally
well tolerated, it is believed to be a promising compound in preventing many
diseases, such as diabetes and its
complications. Unfortunately, this compound exhibits low bioavailability and
solubility.
Pterostilbene is a phenolic
compound originally isolated
from the heartwood
of red sandalwood. Its presence
in grape vines and blueberries
was also reported later. Moreover,
it was also produced in Pterocarpus marsupium, a tree whose wood is primarily used in
the treatment of diabetes by the Ayurvedic
physicians. Pterostilbene shares many chemical,
physiological and pharmacological similarities with resveratrol, a dietary polyphenolic compound that has attracted extensive
interests recently. Structurally, pterostilbene is a dimethylether analog of resveratrol. It is reported to have effects as cancer chemo-preventive anti-diabetic, and anti-ageing. The aim of the study is to assess the bioavailability, safety, and efficacy of NOVAGENERE XAR and NOVAGENERE XAP in 6 healthy, adult, male human subjects. |